Kornimate/medical-research-clean huggingface dataset:
evaluation of postoperative pain and bacterial load reduction with protaper ultimate versus protaper gold rotary systems

Conditions: Post Operative Pain

Summary: this study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating bacterial count reduction and post-operative pain following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.


Eligibility criteria:
inclusion criteria: * patient's age ranges between 22 to 45 years with no sex predilection. * medically free patients. * maxillary permanent premolar teeth: * diagnosed clinically with pulp necrosis. * absence of pain. * radiographic evidence of two roots or single root with double canals. * slight widening in the periodontal membrane space or with peri-apical radiolucency * no response to cold pulp tester and ethyl chloride spray. * patients who can understand modified visual analogue scale (vas). * patients' acceptance to participate in the trial. exclusion criteria: * medically compromised patients. * pregnant women. * if analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. * patients reporting bruxism or clenching. * teeth with: i. vital teeth. ii. single canal maxillary premolar teeth iii. association with swelling or fistulous tract. iv. acute peri-apical abscess and swelling. v. mobility grade ii or iii. vi. pocket depth more than 5mm. vii. previous root canal therapy. viii. non-restorable teeth: hopeless tooth * immature teeth. * radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.
a prospective, multi-center, single arm study evaluating the express™ renal premounted stent system in the treatment of atherosclerotic lesions in the aortorenal ostium.

Conditions: Atherosclerotic Lesions in the Aortorenal Ostium

Summary: the purpose of this study is to demonstrate superior 9-month binary restenosis rate of the express™ renal premounted stent system as compared to an objective performance criterion representative of ptra, for atherosclerotic lesions in the aortorenal ostium.


Eligibility criteria:
inclusion criteria: * eligible for ptra and stenting. * one or more of the following: (1-3) * hypertension * recurrent "flash" pulmonary edema out of proportion to any impairment of left ventricular function * renal dysfunction * single, de novo, or restenotic (from prior ptra) atherosclerotic lesion in the ostium of the renal artery * lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen * renal artery stenosis: bilateral renal artery stenosis (one stent for one lesion in each renal artery) or unilateral renal artery stenosis, including a solitary functioning kidney exclusion criteria: * any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure * advanced renal disease: serum creatinine \> 3.0 mg/dl * end stage renal disease requiring dialysis; or previously diagnosed ephrosclerosis * recent vascular event ≤30 days pre-procedure (i.e. acute coronary syndrome, decompensated heart failure, transient ischemic attack or stroke.) * documented allergy or reaction to iodinated contrast media, including laryngeal edema, convulsions, profound hypotension,unresponsiveness, cardiopulmonary arrest, and clinically manifest arrhythmias (a mild allergy to contrast media that can be pretreated with medication is acceptable) * documented allergy to heparin, acetylsalicylic acid (asa) or clopidogrel * nyha class iv * bleeding diathesis * thrombocytopenia (platelets \< 100,000/mm3) * renal atrophy (renal length ≤ 8 cm determined by renal ultrasound) * patients requiring immunosuppressive therapy * renal allograft * stenosis location in a vascular graft or in a transplant artery angiographic exclusion * total occlusions * thrombus containing lesion * prior treatment of target lesion with stent (in-stent restenosis) * more than one (1) lesion in target vessel * non-atherosclerotic stenosis (fibromuscular dysplasia) * excessive vessel tortuosity * lesion involving a side-branch * lesion in accessory renal artery * abdominal aortic aneurysm \> 3.5 cm * perforated vessels evidenced by extravasation of contrast media

Keywords: renal stent stent atherosclerosis aortorenal ostium renal renal artery ptra
clinical post market clinical follow-up (pmcf) on peripheral arteries treated with sequent® please over the wire (otw)

Conditions: Peripheral Arterial Occlusive Disease

Summary: the aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter sequent® please otw to treat de novo and restenotic lesions in peripheral arteries. it is the intention of this trial to treat suitable target lesions with drug coated balloon (dcb) only.

this study is an non-randomized, prospective, multi-center, non-interventional study (nis=registry, for germany: §23b mpg)

Eligibility criteria:
inclusion criteria (patient): * willingness to treat the target lesion according to the dcb only concept * patients in rutherford classes 2 through 5 * patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (pta) * patients must be 18 years of age * patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol * patients must agree to undergo at least the 12-month clinical follow-up * patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the paclitaxel-eluting pta-balloon catheter or other suitable devices. patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. inclusion criteria (lesion): * peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented\* * diameter stenosis pre-procedure must be 70% * target lesion above and below the knee * vessels must have adequate runoff with at least one vessel to the foot. \*lesions separated by less than 2 cm are considered as one lesion exclusion criteria (all comers): * patient not suitable for revascularization by interventional means
a study to learn about the safety of talzenna for the treatment of breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to learn about the safety of talzenna for the patients with breast cancer that cannot be removed by surgery and has come back. these participants also have a past treatment with medicines that try to stop the growth of cancer cells. this study is seeking for participants who: * have breast cancer that cannot be removed by surgery and has come back * have not used this medicine before. all patients in this study will receive talzenna according to the prescriptions. patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (day 1). however, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.


Eligibility criteria:
inclusion criteria: * patients with brca mutation-positive and her2- negative unresectable or recurrent breast cancer with a history of cancer chemotherapy * no history of previous use of this drug exclusion criteria: * none

Keywords: brca mutation-positive and her2-negative unresectable or recurrent breast cancer
metabolic responses to bariatric surgery

Conditions: Morbid Obesity

Summary: research the genetic and biomechanical markers of human adipose tissue on patients with morbid obesity. additional tissue/fluid collection is also gathered during the time of surgery.

study participation by invitation after complete pre-surgical work up at uc davis health system. patients will be invited to participate if they meet all inclusion criteria's after completing all necessary clinical visits including lab studies, counseling, and participation in educational programs. during the pre-operative visit patients interested in participation will complete all necessary consent documentation. pre-operative labs (blood and urine) will be collected along with additional blood, urine, and fecal samples will be collected pre-operatively. during surgery (roux-en-y gastric bypass surgeries only) tissue collection will include subcutaneous \& omental fat, jejunum, and liver biopsy. post surgery patient will be observed for weight loss and resolution of co-morbidities. at designated times post surgery when lab studies are ordered additional blood/urine samples will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * meet nih criteria for bariatric surgery * between the age of 18-55 * dyslipidemia controlled with medication * impaired glucose metabolism or type 2 diabetes exclusion criteria: * uncontrolled metabolic syndrome (uncontrolled diabetes, htn, dyslipidemia), one or all conditions.

Keywords: bariatric surgery obesity metabolic syndrome diabetes liver disease
a clinical trial evaluating the efficacy and safety of ibi310 in combination with sintilimab, for neoadjuvant treatment of msi-h/dmmr resectable colon cancer

Conditions: MSI-H

Summary: evaluate efficacy and safety of ibi310 (ctla-4 antibody) in combination with sintilimab, for neoadjuvant treatment of msi-h/dmmr resectable colon cancer


Eligibility criteria:
inclusion criteria: 1. signed the informed consent form (icf) and complied with the visit and related procedures stipulated by the plan; 2. at least 18 years old. 3. primary colon adenocarcinoma was histologically confirmed. 4. radiographic assessment showed a resectable stage iib-iii based on ajcc stage viii (ct4 or cn+ only). 5. msi-h or dmmr. 6. radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator. 7. have at least one evaluable lesion according to the recist v1.1 evaluation criteria. 8. the eastern cooperative oncology group performance status (ecog ps) is 0 to 1. exclusion criteria: 1. previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2. prior treatment with anti-pd-1, anti-pd-l1, anti-programmed death receptor ligand 2 (pd-l2) or anti-cytotoxic t lymphocyte-associated antigen 4 (ctla-4) or any other drug acting on t-cell co-stimulation or immune checkpoint pathways (such as ox40, cd137, etc.) and adoptive cellular immunotherapy. 3. concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study. 4. received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.

Keywords: dmmr resectable colon cancer
a study of epoetin beta (neorecormon) in participants with solid tumors

Conditions: Anemia

Summary: this study will evaluate the safety of subcutaneous (sc) epoetin beta (neorecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. the anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * presence of solid tumor(s) * receiving platinum-based therapy capable of inducing anemia exclusion criteria: * red blood cell transfusion within 7 days prior to study drug * relevant acute or chronic bleeding requiring therapy within 3 months prior to study drug * women who are pregnant or breastfeeding
atogepant in real life in italy (giant)

Conditions: Migraine, Prophylaxis

Summary: atogepant is an oral, small-molecule, calcitonin gene-related peptide (cgrp) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (\>= 4 monthly migraine days) with or without medication overuse.

this study is designed to confirm the effectiveness and safety of atogepant in real life. the primary endpoint is the change from baseline in the mean number of monthly migraine days (mmds)across the 12 weeks. secondary endpoints include: change in monthly analgesic intake, numeric rating scale (nrs), headache impact test-6 (hit-6) and migraine disability assessment (midas) scores, \>=50%, \>=75%, 100% responders, \>=50%, \>=75%, 100% responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: • age: \>18 yrs diagnosis of migraine migraine frequency: \>=4 monthly migraine days (mmds) exclusion criteria: patients using concomitant migraine prophylaxis use of onabotulinumtoxina during the previous 12 weeks exposure to anti-cgrp mabs during the previous 24 weeks clinically significant cardiovascular disorders
multimodal assesment of acute cardiac toxicity induced by thoracic radiotherapy in cancer patients

Conditions: Radiotherapy; Complications; Cardiotoxicity; Cancer; Lung Cancer; Breast Cancer; Esophageal Cancer

Summary: the purpose of this study is to evaluate and compare the changes by two modalities: imaging by strain by speckle tracking and magnetic resonance versus soluble markers of cardiac dysfunction as early predictors of cardio-toxicity in cancer patients receiving low or high doses of radiotherapy.


Eligibility criteria:
inclusion criteria: * ≥18 year-old patients * with histologically confirmed thoracic cancer (breast, esophagus or lung) * recommendation of thoracic radiotherapy (rt) with curative intent * with or without chemotherapy * all patients must be able to read and understand spanish * all patients must sign informed consent form. exclusion criteria: * patients with no medical records, * pregnant * previously diagnosed with severe left ventricular dysfunction or a cardiac insufficiency * patients with metastatic disease and indication of palliative rt * patients with significant comorbidities associated to a \<5 year life expectancy. * patients previously treated with thoracic rt
osteoarticular sepsis in intensive care units

Conditions: Osteoarticular Infection; Intensive Care Patients

Summary: this is an ambispective observational study of patients admitted to critical care with a diagnosis of osteoarticular infection on material device (mainly knee and hip prostheses). the main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. we also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in france. this is a descriptive and analytical observational study open to all french public and private hospitals. patient data will be retrieved prospectively from patient source files. only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.


Eligibility criteria:
inclusion criteria: * patient at least 18 years old. * no opposition from the patient (or surrogate in case of death) * stay in critical care (intensive care or continuing care) between 2018 and 2021 of at least 48 hours, with the principal or associated diagnosis of an osteoarticular exclusion criteria: * patient under legal protection. * pregnant or breast-feeding patient. * patient deprived of liberty.

Keywords: osteoarticular sepsis sepsis osteoarticular prothetis intensive care critical care
evaluation of a new technique to fill the defect generated after conservative surgery in breast cancer

Conditions: Breast Conserving Surgery

Summary: the placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. it could also potentially improve the quality of life of patients

conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. objective: to demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments. methodology: prospective randomized clinical trial, controlled with blind evaluator. inclusion criteria: women with breast cancer candidates for conservative surgery. intervention: in the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). controls: usual surgical procedure. main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.

Eligibility criteria:
inclusion criteria: - women, over 18 years old, with breast cancer who attend breast pathology consultations at the sant pau hospital in which conservative surgery is indicated. exclusion criteria: * multicentric tumors * tumors larger than 5cm * locally advanced tumors (t4): deep plane involvement or skin involvement * patients in stages iv (distance dissemination) * patients who need mastectomy * patients with disabilities or who do not understand the terms of the study or do not agree to participate in the study

Keywords: breast neoplasms breast conserving surgery
association between the effect of glucocorticoid pulse therapy on neuromyelitis optica (nmo) and gene polymorphism

Conditions: Glucocorticoid Resistance; Gene; Neuromyelitis Optica

Summary: aims of this study are to observe the correlation between abcb1、vdr、tbx21、nr3c1 and other gene polymorphisms and the effect of glucocorticoid shock therapy on neuromyelitis optica. investigators plan to include patients with neuromyelitis optica who will receive glucocorticoid shock therapy prospectively. the patients are divided into glucocorticoid sensitive (gs) group and glucocorticoid resistance (gr) group according to the change of central vision after treatment. patients' clinical data will be collected and blood samples are needed for single nucleotide polymorphism (snp) typing test. through statistical analysis, the data differences between gs group and gr group were compared, and the effects of clinical indexes and gene polymorphisms on the efficacy of glucocorticoid shock therapy in the treatment of neuromyelitis optica should be analyzed.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of neuromyelitis optica * chinese han nationality, gender is unlimited; * must be able to accept methylprednisolone pulse therapy exclusion criteria: * other optic nerve diseases, such as ischemic, compressive, invasive, traumatic, toxic and nutritional metabolic, hereditary optic neuropathy; * visual path and central lesion on optic chiasma; * other eye diseases, such as anterior segment lesions, retinopathy, macular lesions, ametropia, glaucoma, etc; * non-organic visual impairment; * treated with glucocorticoid in two weeks.
bipap automatic servo ventilation (autosv) advanced in central apnea patients

Conditions: Cheyne-Stokes Respiration; Sleep Apnea, Central

Summary: pilot study testing the bipap autosv advanced algorithm during full night, in-lab polysomnography (psg) and 3 months at home on patients with central sleep apnea, hunter cheyne stokes respiration, or complex sleep apnea.

participants who qualify will be scheduled for one full night, attended diagnostic psg, one full night attended continuous positive airway pressure (cpap) titration, and one full night attended bipap autosv advanced titration psg. participants will be provided a bipap autosv advanced to use at home for 90 days.

Eligibility criteria:
inclusion criteria: 1. males and females, ages 21-75. 2. able and willing to provide written informed consent. 3. diagnosis of central sleep apnea such as hunter cheyne stokes breathing, complex sleep apnea, or central apnea with current daily opioid use or any other predominant central sleep apnea. 1. for participants diagnosed with hunter cheyne stokes breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude and either a central apnea index (cai) ≥ 5/hour or the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended diagnostic polysomnogram (psg). 2. for participants diagnosed with central sleep apnea with current daily opioid use or any other predominant central sleep apnea, an apnea/hypopnea index (ahi) ≥ 15 and cai \> 5 from an attended diagnostic psg. 3. for participants diagnosed with complex sleep apnea, an ahi ≥ 15 and cai \> 5 from a cpap titration. 4. systolic blood pressure \> 80 mm hg at visit 1. 5. agreement to undergo a full-night, attended diagnostic psg. 6. agreement to undergo a full-night, attended cpap titration psg. 7. agreement to undergo a full-night, attended bipap automatic servo ventilation (autosv) advanced titration psg exclusion criteria: 1. active participation in another interventional research study. 2. diagnosis of acute decompensated heart failure. 3. surgery of the upper airway, nose, sinus or middle ear within the last 90 days. 4. major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. for example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure. 5. qualifying for or awaiting heart transplantation. 6. currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous). 7. at home treatment with adapted servo ventilation (asv) or bilevel positive airway pressure (pap) therapies. 8. unable to use pap therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues. 9. participants in whom pap therapy is medically contraindicated. 10. uncontrolled hypertension (systolic ≥ 200 mm hg/diastolic ≥ 120 mm hg). 11. narcolepsy. 12. untreated restless legs syndrome. 13. periodic limb movement arousal index \> 20/hr.